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Desara Blue TVez 2.7

Caldera Medical, Inc. · Model CAL-DS01BTV27 · UDI-DI 00890594000193

OTNPWJ Prescription
1
510(k) clearances
38,668
Adverse events (376 deaths)
1
Recalls
30
Facilities

Description

Desara Blue TVez 2.7mm for the treatment of female stress urinary incontinence (SUI) or mixed incontinence

Recalls

DateFirmReason
2014-10-15American Medical Systems, Inc.During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components s

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.